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Drugs reference index «Contraceptives, Transdermal Patch (Combination Product)»

Contraceptives, Transdermal Patch (Combination Product)

Pronunciation: kon-tra-SEP-tivClass: Hormonal contraceptive

Trade Names:Ortho Evra- Patch, transdermal norelgestromin 6 mg/ethinyl estradiol 0.75 mg

Pharmacology

Inhibits ovulation by suppressing gonadotropins; alters cervical mucus, which increases the difficulty of sperm entry into the uterus; and alters the endometrium, which reduces the likelihood of implantation.

Indications and Usage

Prevention of pregnancy.

Contraindications

Thrombophlebitis; thromboembolic disorders; history of deep vein thrombophlebitis; cerebral vascular disease; coronary artery disease; valvular heart disease with complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast; carcinoma of the endometrium; estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy; jaundice with prior hormonal contraceptive use; acute or chronic hepatocellular disease with abnormal liver function; hepatic adenomas or carcinomas; pregnancy; hypersensitivity to any component of the product.

Dosage and Administration

Adults and Adolescents who have reached menarche

Transdermal Apply 1 patch each week for 3 weeks (21 days). Apply every new patch on the same day of each week (patch change day). Week 4 is patch-free and withdrawal bleeding is expected at this time. On the day after week 4 ends, a new 4-wk cycle is started by applying a new patch.

General Advice

  • The patch should not be cut, damaged, or altered in any way.
  • For the first day–start method, the patch should be applied during the first 24 hours of the menstrual cycle. A nonhormonal back-up contraceptive (eg, condom) should be used concurrently for the first 7 consecutive days of the first treatment cycle if therapy is started after day 1 of the menstrual cycle.
  • For the Sunday-start method, the first patch should be applied on the first Sunday after the start of the menstrual cycle. Back-up contraception must be used for the first week of the first cycle. If the menstrual period begins on a Sunday, the first patch should be applied on that day and no back-up contraception is needed.
  • The patch should be applied to clean, dry, intact, healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing. Do not apply patch to skin that is red, irritated, or cut, or on the breasts. Each patch should be applied to a new spot on the skin to help avoid irritation, although they may be kept in the same anatomic area.
  • No makeup, creams, lotions, powders, or other topical products should be applied to the skin area where the patch is or will be placed.
  • If the patch is partially or completely detached for less than 1 day, the woman should try to reapply it to the same place or replace it with a new patch immediately. No back-up contraception is needed and the patch change day will remain the same.
  • A patch should not be reapplied if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously become loose or fallen off. If a patch cannot be reapplied, a new patch should be applied immediately. Supplemental adhesives or wraps should not be used to hold the patch in place.
  • If the patch is partially or completely detached for more than 1 day or if the woman is unsure how long it has been detached, she should stop the current contraceptive cycle and start a new one immediately by applying a new patch. There is now a new Day 1 and new patch change day. Back-up contraception must be used for the first week of the new cycle.
  • If a woman forgets to change her patch at the start of any patch cycle, she should apply the first patch of her new cycle as soon as she remembers. There is now a new Day 1 and new patch change day. Back-up contraception must be used for the first week of the new cycle.
  • If a woman forgets to change her patch in the middle of the patch cycle (Week 2/Day 8 or Week 3/Day 15) for 1 or 2 days, she should apply a new patch immediately. The next patch should be applied on the usual patch change day. No back-up contraception is needed. If it has been more than 2 days, she should stop the current contraceptive cycle and start a new one immediately by applying a new patch. There is now a new Day 1 and new patch change day. Back-up contraception must be used for the first week of the new cycle.
  • There should not be more than a 7-day patch-free interval. If this occurs, the woman may not be protected from pregnancy and back-up contraception (eg, condoms) must be used for 7 days.

Storage/Stability

Store at 59° to 86°F. Store patches in their protective pouches. Apply immediately upon removal from the protective pouch. Do not store in the refrigerator or freezer.

Drug Interactions

Acetaminophen, ascorbic acid, atorvastatin, itraconazole, ketoconazole

Ethinyl estradiol concentrations may be elevated, increasing the risk of adverse reactions.

Acetaminophen, clofibric acid, lamotrigine, morphine, salicylic acid, temazepam, valproic acid

Plasma concentrations of these agents may be reduced, decreasing their effectiveness.

Antibiotics (eg, tetracycline), barbiturates (eg, phenobarbital, primidone), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, rifampin, St. John's wort, topiramate

Hormonal contraceptive effectiveness may be decreased. Use an additional nonhormonal form of birth control during concomitant therapy.

Benzodiazepines, beta-blockers (eg, metoprolol, propranolol), caffeine, corticosteroids (eg, prednisolone), cyclosporine, selegiline, theophylline, tricyclic antidepressants

Plasma concentrations of these agents may be elevated, increasing the risk of adverse reactions.

Protease inhibitors (eg, ritonavir)

Increase or decrease in the plasma levels of estrogens and progestins has been noted.

Laboratory Test Interactions

Increased

Prothrombin and factors VII, VIII, IX, and X; norepinephrine-induced platelet aggregability; thyroid-binding globulin leading to increased circulating total thyroid hormone as measured by protein-bound iodine; T4 by column or by radioimmunoassay; other binding proteins; sex hormone–binding globulins, which results in elevated levels of total circulating endogenous sex steroids and corticoids (however, free or biologically active levels either decrease or remain unchanged); triglycerides and other lipids and lipoproteins.

Decreased

Antithrombin III; free T3 resin uptake; glucose tolerance; serum folate levels.

Adverse Reactions

Cardiovascular

Hypertension, MI.

CNS

Headache (9% to 22%); cerebral hemorrhage, cerebral thrombosis.

EENT

Retinal thrombosis.

GI

Abdominal pain, nausea (9% to 22%); mesenteric thrombosis.

Genitourinary

Breast symptoms, menstrual cramps (9% to 22%).

Hematologic-Lymphatic

Arterial thromboembolism, thrombophlebitis, venous thrombosis.

Hepatic

Benign liver tumors, gallbladder disease, hepatic adenomas.

Local

Application-site reaction (9% to 22%).

Respiratory

Upper respiratory tract infection (9% to 22%); pulmonary embolism.

Precautions

Warnings

Smoking

Cigarette smoking increases the risk of serious CV adverse reactions. The risk increases with age (older than 35 yr of age) and smoking at least 15 cigarettes/day. Women using hormonal contraceptives should not smoke.

Monitor

Monitor blood glucose in women with diabetes. Perform routine annual medical evaluation, including physical examination and relevant laboratory tests. Closely monitor women being treated for hyperlipidemia. Carefully monitor women with conditions that may be aggravated by fluid retention.

Pregnancy

Category X .

Lactation

Undetermined; however, contraceptive steroids are excreted in breast milk.

Children

Safety and efficacy are expected to be the same for postpubertal adolescents younger than 16 yr of age and for patients 16 yr of age and older. Use before menarche is not indicated.

Elderly

Not indicated in elderly patients.

Hepatic Function

Estrogens may be poorly metabolized in patients with impaired liver function. Discontinue use if jaundice develops.

Bleeding irregularities

Breakthrough bleeding and spotting may occur.

Blood pressure

Encourage women with hypertension or hypertension-related diseases to use another nonhormonal method of contraception.

Body weight

Clinical trials suggest that norelgestromin/ethinyl estradiol transdermal may be less effective in women weighing 90 kg (198 lb) or more than in lower-weight women.

Carbohydrate and lipid metabolism

Glucose tolerance may be decreased. Changes in serum triglycerides and lipoprotein levels have been reported. Some progestins may elevate LDL levels and interfere with control of hyperlipidemia.

Carcinoma

Risk of breast cancer may be slightly increased but decreases over time after oral contraception discontinuation, and the increased risk disappears by 10 yr after cessation of use.

CV disease

Increased risk of MI has been attributed to hormonal contraceptive use, primarily in smokers or women with underlying risk factors for coronary artery disease (eg, diabetes, hypertension, obesity). Increased risk of thrombotic disease associated with hormonal contraceptive use is well established. Use with caution in women with CV disease risk factors (eg, hyperlipidemia).

Cerebrovascular disease

Increase in the relative and attributable risk of cerebrovascular events (eg, thrombotic and hemorrhagic strokes) has been reported. The risk is greatest among hypertensive women who are older than 35 yr of age and who smoke.

Depression

Use with caution in women with a history of depression.

Ectopic pregnancy

Ectopic or intrauterine pregnancy may occur in contraceptive failure.

Fluid retention

May occur. Use with caution in women with conditions that may be aggravated by fluid retention.

Gallbladder disease

Existing gallbladder disease may be worsened or development of this condition may be accelerated in previously asymptomatic women.

Headache

Discontinue the contraceptive patch if there is exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe.

Hepatic neoplasm

Benign hepatic adenomas, which may cause death through intra-abdominal hemorrhage, have been associated with hormonal contraceptive use.

Hormone exposure

The pharmacokinetic profile for the contraceptive patch is different from that of oral contraceptives in that it has higher steady-state concentrations and lower peak concentrations. Increased estrogen exposure may increase the risk of adverse reactions, including venous thromboembolism.

Immobilization

Discontinue during and following prolonged immobilization.

Surgery

Discontinue at least 4 wk prior and for 2 wk after elective surgery associated with an increase in risk of thromboembolism.

Vascular disease

A positive association has been seen between amount of estrogen and progestin in hormonal contraceptives and risk of vascular disease. Many progestational agents have been reported to decrease HDL, which is associated with an increased incidence of ischemic heart disease.

Visual abnormalities

Retinal vascular thrombosis may occur, leading to loss of vision, sudden onset of proptosis, diplopia, or migraine.

Overdosage

Symptoms

Nausea, menstrual irregularities, vaginal bleeding, vomiting.

Patient Information

  • Advise women that this product does not protect against HIV infection or other STDs.
  • Advise women to contact health care provider if they experience any of the following symptoms: breast lumps; crushing chest pain or heaviness in the chest; coughing blood; dark-colored urine or light-colored bowel movements; difficulty sleeping, weakness, lack of energy, fatigue, or a change in mood; dizziness or fainting; irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days; pain in calf; loss of appetite; problems with vision or speech; sharp chest pain; severe pain, swelling, or tenderness in the abdomen; sudden fever, vomiting, diarrhea, dizziness, fainting, or sunburn-like rash on the face or body; sudden shortness of breath; weakness or numbness in arm or leg; sudden partial or complete loss of vision; sudden, severe headache or vomiting; swelling of the fingers or ankles; tiredness; yellowing of the skin or whites of the eyes, especially with fever.
  • Instruct women that every new patch should be applied on the same day of each week and that only 1 patch should be worn at a time.
  • Instruct women to apply the patch to clean, dry, intact healthy skin on the buttock, abdomen, upper outer arm, or upper torso. The patch should not be placed on skin that is red, irritated, or cut, or on the breasts. To avoid irritation, apply each new patch to a different place on the skin. Creams, oils, powders, or makeup should not be applied to skin where the patch is or will be placed.
  • Advise women that the patch should not be cut, damaged, or altered in any way.
  • Advise women that they should never have the patch off for more than 7 days in a row. This may leave them unprotected against pregnancy. If a woman is not sure what to do about mistakes with a patch, instruct her to use a back-up method of contraception (eg, condoms, diaphragm) every time she has intercourse and to contact her health care provider for instructions.
  • Advise women that if they miss 2 menstrual periods in a row to contact their health care provider because they may be pregnant.
  • Advise women that contact lens wearers who develop vision changes or changes in lens tolerance should be assessed by an ophthalmologist.
  • Advise women that the used patches still contain some active hormones. The sticky sides of the patch should be folded together and the folded patch placed in a sturdy container (preferably with a child-resistant cap) and the container thrown in the trash. Used patches should never be flushed down the toilet.
  • Advise postpartum women who elect not to breast-feed to start hormonal contraceptive no earlier than 4 wk after delivery.

Copyright © 2009 Wolters Kluwer Health.

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